CompletedPhase 1

Safety and Tolerability of Liraglutide in Healthy Volunteers and Subjects With Type 2 Diabetes

A Randomised, Double-blind, Placebo-controlled, Dose-escalation, Parallel-group, Single and Multiple Dosing Trial of NN90-1170 in Healthy Volunteers and Patients With Type 2 Diabetes to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Type 2 diabetes

Eligibility highlights

•BMI 19-30•HbA1c ≤11%•Healthy volunteers

Primary endpoint

•Area under the Curve

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01507285

Org study IDNN2211-1189

Timeline

Milestones

Study first posted2012-01-10estimated

Last update posted2023-11-02actual

Study start1999-08 (month precision)

Primary completion1999-11actual (month precision)

Study completion1999-11actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Healthy volunteersType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•HEALTHY VOLUNTEERS

•Healthy subjects aged 18-45 years inclusive

•Healthy subjects are defined as individuals free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and clinical laboratory test results

•Women who are not of childbearing potential

•Signed and dated written informed consent obtained

•Body mass index (BMI) within the range 19-30 kg/m^2, inclusive

•SUBJECTS WITH DIABETES

•Subjects aged 40-70 years inclusive

•Subjects diagnosed with type-2 diabetes and a duration of diabetes of more than 12 months

•Women who are not of childbearing potential

•Signed and dated written informed consent obtained

•Fasting C-peptide at least 0.3 nmol/l and blood glucose at least 7 mmol/l

•Subjects currently on diet and/or OHA (oral hypoglycemic agents) for at least six months

•Body mass index (BMI) below 35 kg/m^2

•HbA1c (glycosylated haemoglobin) below 11%

•Stable on current medication for at least 3 weeks prior to dosing in this study

Exclusion criteria

•HEALTHY VOLUNTEERS

•Clinically relevant abnormal history or physical findings (e.g. cancer) at the screening assessment, which could interfere with the objectives of the study or the safety of the subject's participation

•Clinically relevant abnormalities of laboratory values or ECG at the screening evaluation

•Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous

•Blood pressure and heart rate in seated position at the screening examination outside the ranges 90-150 mmHg systolic, 40-90 mmHg diastolic: heart rate 40-100 beats/min

•History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women)

•Alcohol intake within 48 hours prior to visit

•Evidence of drug abuse on urine testing at study entry

•The subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period

•Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies

•History of significant drug allergy or drug hypersensitivity

•SUBJECTS WITH DIABETES

•Use of any drug (except for oral hypoglycaemic agents (OHAs)) which in the Investigator's opinion could interfere with the blood glucose level (e.g. insulin, systemic corticosteroids, thiazides)

•Recurrent severe hypoglycaemia as judged by the Investigator

•Clinically relevant abnormalities of laboratory values or ECG at the screening evaluation

•Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous

•Blood pressure and heart rate in seated position at the screening examination outside the ranges 110-160 mmHg systolic, 60-90 mmHg diastolic: heart rate 40-100 beats/min

•History of drug or alcohol abuse (alcohol abuse is defined as intake of more than 28 units weekly in men and more than 21 units weekly in women)

•Alcohol intake within 48 hours of visit

•Evidence of drug abuse on urine testing at study entry

•The subject smokes 10 cigarettes or more, or the equivalent, per day and is unable to refrain from smoking during 3 days prior to the first dosing day and during the confinement period

•Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies

•History of significant drug allergy or drug hypersensitivity

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint/low confidence

Area under the Curve

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to maximum concentration

Tmax

descriptive

Secondary/protocol endpoint

t½, terminal half-life

Half-life

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

The pharmacokinetics, pharmacodynamics, safety and tolerability of NN2211, a new long-acting GLP-1 derivative, in healthy men.
Diabetologia2002 Feb (month)PMID11935150doi:10.1007/s00125-001-0719-zvia CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.